False alerts about nonexistent allergen risks in products made with non-GMO Indian soybean lecithin additive and their Kafkaesque management-including omissions, passing the buck, and abuses of power, in the various levels of Eurocratic and ministerial, regional, and local bureaucracy-are causing serious damage to food supply chains and social disasters in Italy and the EU.
The widespread presence of minimal allergen residues in emulsifier additive E 322 has already been described in previous articles, with evidence of the need to ensure coordination of risk analysis both at the European level and within member states (1,2). Also stressing the need to limit corrective actions to only cases of actual public health risk. (3)
Bureaucrats in every control room, however, indulge in the blame game, (4) downgrading their roles from public managers to stolid paper-pushers rather than downgrading risk from ‘serious’ to ‘nonexistent. And by the hour, workers in the affected industries risk unemployment caused by the crisis of a procured alarm, which allergic consumers experience with infinite stress.
Indian soybean lecithin, the false alerts
False alerts about the presence of impurities consisting of peanut residues in soy lecithin produced in India have been occurring since April 2022. The only member state not to report a ‘serious risk‘ to food safety was Germany. Instead, Spain and Italy have deployed sirens, but without performing the proper risk analysis that is a prerequisite for any alert. The chronology of events follows.
Italy, the silly alert
The Italian alert on Indian soy lecithin was triggered in Lombardy on 5/28/22, following a distributor’s self-report to the ASL in the territory. Which-instead of seeking feedback from the responsible importer for an initial risk analysis-generated alarm over the possible presence of peanut residues at levels close to the detection limits of available analytical methods. (5)
5/31/22 the Lombardy ASL, without conducting official sampling or risk analysis suitable for assessing the actual margin of exposure of consumers consuming foods where such lecithin powder is used in minimal amounts (0.1-0.2%), notified a ‘serious risk‘ in the Rapid Alert System on Food and Feed (RASFF).
However, the available analyses revealed additive impurities in the range of 0.2-2.5 ppm of the allergen peanut protein (therefore unobtainable in the final products, without the need for further analysis by a simple arithmetic operation). Indeed, Germany, albeit with 300 times higher residue levels, had notified the RASFF of a simple information for attention (instead of an alert).
Scientific risk analysis
On 3.6.22 the importer of the alerted lecithin-one of the largest lecithin experts on the Old Continent-delivered to the distributor a scientific risk analysis-written by our team of DO and shared with the association representing allergy patients, Food Allergy Italia – aimed at ascertaining whether there is any risk on any food matrix where soy lecithin (emulsifying additive E 322) has been used.
The aforementioned analysis-performed with the Vital 3.0 method, prepared by Allergen Bureau and validated both by the international scientific community and by various institutions deputed to risk analysis (e.g., BfR in Germany)-showed the absence of any risk to vulnerable segments of the population. Albeit by simulating a worst-case scenario, i.e., contamination levels far higher than those detected, as well as the use of the additive lecithin to an extent 3 times higher than industrial practices.
Communication of(the absence of) risk
On 9.6.22 the writer shared the aforementioned analysis with the head of the Ministry of Health’s Office in charge of ‘Food Crisis and Emergency Management,’ with explicit requests to:
– verify the correctness of its pro-veritate technical-legal opinion, thus ascertaining the absence of any food safety and public health risk, which is the sine-qua-non conditio for the activation of the corrective actions prescribed by the General Food Law (EC Reg. 178/02, Article 19),
– thus proceed to the due (absence of) risk assessment on all foods containing the alerted soy lecithin additive <0.5 percent in the products’ formula/recipe,
– Update the reporting in the national and European food and feed rapid alert systems (iRASFF, RASFF) accordingly.
Second risk analysis
6/16/22 A Campania industry leader in the production of ingredients for businesses and bakery and pastry industries, after receiving notification of the alert in question, in turn transmitted a scientific analysis – carried out by the writer and shared with Food Allergy Italia – demonstrating the absolute absence of food safety risks on its batches of products where the soy lecithin in question had been used as a food additive, in a proportion that was, moreover, no greater than 0.2%.
This analysis, like the previous one, was conducted using the Vital 3.0 method (using the VITAL Calculator 3.1.4), based on product data sheets attested by numerous international certifications. Assuming, conservatively, the presence of peanuts in the additive at 60 times the concentration detected in the lecithin batches from which the alert was triggered. To support the mathematical simulations, both analyses included a brief supporting scientific review.
Second sharing of(the absence of) risk
On 6/16/22 the writer shared the concrete analysis of the non-existence of any risk on the products of the Campania industry to the same ministerial executive who should be in charge of handling food alerts. With further urging you to want to verify its correctness and assume responsibility related to your assignment.
The activation of alert in numerous regions and territorial health authorities and the real risk of uncoordinated interventions – based on risk analyses that each entity should in turn perform but often lacks the necessary expertise and resources – indeed postulates the duty of coordination of the aforementioned office.
Among other things, this office is the National Point of Contact in the European Food and Feed Alert System (RASFF) and is responsible for classifying risk, as well as providing timely updates(follow-up) in this regard. (6)
Request for coordination to the European Commission
Therefore, on 21.6.22 the writer approached the Director General of DG Sante(Directorate General for Food Safety and Public Health) at the European Commission, and the Head of its Unit G.4(Food Hygiene & Fraud) responsible for alerts in the EU, so that they in turn:
– noted the presence on the RASFF of one notification for information (Germany) and two for alert (Spain, Italy), all concerning the presence of peanut residues in food additive soy lecithin produced in India and used in a very wide variety of food products,
– given the substantial difference in approach among the 24 member states involved in these notifications, where the member country with the highest levels of peanut in lecithin (Germany, >200 ppm) has assessed the nonexistence of risk on products containing it as an additive, precisely by applying the only validated international standard for performing such analysis (Vital 3.0), and several other countries (e.g., Belgium, the Netherlands, Bulgaria, UK) have followed the same approach of concretely assessing the absence of risk to allergic consumers associated with the consumption of foods containing infinitesimal portions of the additive with impurities that are not even detectable by analysis,
– acknowledged the unacceptable delay of the Italian National Point of Contact in carrying out the necessary concrete analysis of the safety risk of food produced through the use of soy lecithin imported into Italy, whose levels of impurities with peanut are moreover the lowest so far recorded in the EU,
provided for the coordination of risk analysis and management in the domestic market, where 25,000 tons of Indian soy lecithin potentially affected by impurities and yet harmless to allergic patients was imported in 2021 alone, subject, however, to a concrete risk analysis when used as an additive in the 5 million tons of foodstuffs that in 2021 alone (the year to which the cross-contact) have been produced and consumed in the entire EU and various other countries (63 so far involved by follow-up in the three RASFF notifications). Without a single related allergic reaction ever having been recorded.
Abuse of power, first act
6/23/22 a Campania ASL transmitted to the glorious industry based there, ‘for your information‘, a email where it referred to generic indications of withdrawal and recall of products, without having performed as it is its primary task the risk analysis that is a prerequisite for the adoption of corrective actions provided for by reg. EC 178/02 in Article 19. Such a regulation, it should be noted, has supra-constitutional rank in the hierarchy of sources of law, and its disapplication certainly cannot be justified by reference to a guideline adopted in the State-Regions Conference.
The said uncertain communication is the tipping point of a systemic blame game, where
– competent authority omits the required risk analysis. Without taking any account of the scientific analysis promptly notified by the industry in question or performing official sampling of the products, let alone having collected reports of allergic reactions of any kind. It is emphasized that the timely evaluation of the food business operator’s analysis and subsequent actions (pursuant to EC Reg. 178/02, Article 19) is a prerequisite for justifying the administrative act if the authority decides to challenge the operator’s management,
– instead of justifying its act with the dutiful analysis of the risk posed to it, the territorial ASL reported that it had approached the regional node. Who in turn, instead of evaluating the risk analysis produced by the operator, had asked for enlightenment from the alert office(nomen ipsum) of the Ministry of Health,
– the ministerial manager of the alert office in turn, instead of examining the data offered by the Campania industry as proof of the guarantee of the absolute safety of its products, disavowed his own competence by asserting the hypothetical responsibility of another office that instead deals with labels. As if analyzing the risk of an immune reaction to the intake of 0.05 ppm allergenic protein (equal to 0.2 ppm peanut, not even detectable by CERN) by an allergic patient has anything to do with product labeling.
First warning
On 6/28/22, the writer notified the Campania ASL of the notice to cancel its own order 6/23/22 in self-defense. Highlighting how the same was devoid of any justification and the albeit uncertain recall order and/or safe food recall mentioned in it is the cause of an unjustified multimillion-dollar value damage that jeopardizes the survival of a Campania industry with 130 workers. Industry that has given excellent evidence of its unimpeachable responsibility.
Indeed, the Campania-based industry had activated a temporary blocking of batches where the additive was used, through instant communication to its distributors and customers made possible by an optimal traceability system, certified for compliance with international food safety management schemes (IFS, BRC), among others. And it lifted that blockade only after receiving scientific confirmation and mathematical demonstration of the safety of its products.
Coordination solicitation to the European Commission
On 6/29/22 the writer updated the European Commission on theescalation of the alert provoked by the Campania ASL, which in turn provoked the activation of the health authorities of Spain, Romania, Bulgaria and Croatia. The importer in Italy of the Indian soy lecithin was in turn informed of the activation of the alert in France. In addition to that of numerous ASLs in every Region of Italy in pursuit of Campania’s industry clients.
The ‘responsible’ authorities in the various territories all in turn executed the recall notice for an alert based on an ideological misrepresentation in a public act, having been identified as seriously risky foods instead of safe ones. However, DG Sante has not dignified the two written petitions in the interest of more than 800 companies overwhelmed by the collective delirium of bureaucrats with a response, nor has it fulfilled its duties to date to coordinate the European Risk Analysis Network.
Policy intervention
29 and 30.6.22 the writer then submitted the matter to the Undersecretary of State at the Ministry of Health Prof. Pierpaolo Sileri, whose Secretariat responded immmediately notifying the registration of the urgent file ‘Omission of official acts in the analysis and management of food alerts‘ with appropriate protocol SSS.AOP.MM.1059.
On 1.7.22, Undersecretary Sileri’s Secretariat confirmed that it had immediately concerned the relevant ministerial offices. In any case, the writer also involved Undersecretary Paolo Costa and Campania Regional Governor Vincenzo De Luca. Having regard to the Undersecretary’s delegation of authority and the concurrent jurisdiction of the regions over food safety.
Abuse of power, second act
On 1.7.22, the director of the Prevention Department and the ‘corporate node manager’ of the Campania ASL replied to the writer’s 28.6.22 warning with the rhetoric already noted in the same ASL’s previous communication. And therefore, instead of finally reviewing the scientific risk analysis and forwarded to the aforementioned ASL on the now distant 16.6.22, and expressing where appropriate timely concerns on specific topics possibly worthy of further study:
– dismissed the aforementioned analysis as ‘arbitrary,’ blatantly ignoring its content (since the Vital 3.0 scientific system does not allow for arbitrary margins in interpreting the results of mathematical calculations) and international recognition,
– omitted the required risk analysis, an activity that should have been performed urgently as early as 16.6.22 for public health reasons (which, moreover, did not exist),
– attached e-mail exchanges between various ministry offices, reconfirming the ongoing blame-shifting on the three levels-local, regional and national,
– adduced the need to calmly perform an official sampling of the products of the blameless and diligent Campania enterprise at its sole expense in the five days to follow,
– emphasized that ‘only as a result of the above-described process of detection
any further and different determinations may be made, failing which the provisions already put in place will remain in force‘.
Ongoing emergency
Grotesque management of this alert by the ‘competent’ offices of ASL, Regions, the Ministry of Health and the European Commission is aggravating, day by day, the terrible damage to an industry in Campania on which the livelihood of hundreds of families, considering also the supply chain generated by its activities, and of the more than 800 customers to whom safe food was provided, both for the general population and for the allergy patient community. (7)
Direct harms that include the continued diversion of human resources from their ordinary duties to reassure and support clients and their customers, interact with authorities, manage collection operations, and deal with logistics costs. But mostly indirect damages, related to the damage to international reputation after customers, due to abuses of power, found themselves under siege by the authorities with the threat of having to block goods and trigger recalls and recalls in turn. Resulting in the risk of significant loss of customers and market share.
Added to this is the damage suffered by the importer in Italy, itself an IFS(International Food Standard) certified company that has been selecting the best high quality soy lecithin for its customers for 20 years. Lecithin produced by a leading Indian industrial group, FSSC 22000 certified (international standard ISO 22000:2018), in a hi-tech factory that packages products in a ‘clean room’ (highest level of protection from contaminants).
False alarm for allergic consumers
Even greater harm is caused by the ‘passing the buck’ by health authorities to the several million allergic consumers in Italy and the European Union. The which
– are already plagued by the systematic illegality of labels redundant with voluntary and generic claims such as ‘may contain traces of … (allergens)‘, (8)
often added to labels without prior analysis of the actual risk of food contamination (which in turn should follow the Vital 3.0 method),
– cannot buy bulk food or eat meals away from home because of the ubiquitous violation of consumer information rules that health authorities persist in tolerating in many EU member states, (9)
and are now being frustrated by false alerts about safe foods and risk the further unavailability of tens of thousands of products on the shelf.
Food waste
The recall and recall generalized and unjustified tens of thousands of safe foods is also causing unjustified food waste that, in the absence of a responsible decision on allergen risk analysis and management, could be extended to tens of millions of tons of healthy and safe foods in Italy and the EU.
Latest warning
On 2.7.22 the writer has served the latest warning to the managers in charge of the Campania ASL, so that they cancel in self-defense and without further delay their unfounded, therefore illegitimate orders 23.6.22 and 1.7.22 of withdrawal and recall of the products of the industry mentioned several times, updating accordingly the alert communication system at the national and European level.
Health Minister Roberto Speranza and Health and Food Safety Commissioner Stella Kyriakides are urged to take immediate action to put an end to an affair that has exposed the complete irresponsibility of officials in charge of coordinating food safety risk analysis and management. Who may not be up to the task of handling such delicate assignments, where risk management skills are crucial and tragically wrecked here.
The Commissioner Stella Kyriakides is also requested to question EFSA, in order to want to assess the suitability and completeness of the Vital 3.0 allergen risk analysis method, which is emphasized to have been prepared and updated by the leading experts on food allergies, former members of FARE (Food Allergy Research and Education). In order for its use to be imposed on all food business operators as early as the self-inspection stage, in execution of reg. EU 2021/382. (10)
Justice
Operators harmed by this poor management of false alerts will be able to obtain protection in the competent judicial authorities, in Italy and Luxembourg, including for the purpose of compensation from the administrations and managers responsible. Our team is willing to support these actions so that justice is done once and for all.
A senior investigating magistrate has meanwhile been informed of the actions perpetrated by ASL executives to the detriment of leading industry in Campania, so that he would like to acquire the records of the administrative proceedings still pending and assess whether there are any indictable offenses.
‘How miserable is life among the abuses of power‘ (quoting. Franco Battiato, Up patriots to arms).
Dario Dongo
Cover elaborated on vignette © 2021 CartoonStock Ltd, license 1.7.22
Notes
(1) Dario Dongo. RASFF, peanuts in soy lecithin from India. Risk analysis. GIFT (Great Italian Food Trade). 3.6.22
(2) Dario Dongo. Allergen contamination risk analysis, the unresolved issue. GIFT (Great Italian Food Trade). 6/21/22, https://www.greatitalianfoodtrade.it/sicurezza/analisi-del-rischio-contaminazione-allergeni-il-nodo-irrisolto
(3) Safe food recall and recall? Attorney Dario Dongo replies. FARE(Food and Agriculture Requirements). 6/28/22, https://www.foodagriculturerequirements.com/sicurezza/ritiro-e-richiamo-di-alimenti-sicuri-risponde-lavvocato-dario-dongo/
(4) Annamaria Testa. Scarcabarile, the game of blaming someone else. New and useful. 7/14/19, https://nuovoeutile.it/scaricabarile-il-brutto-gioco-di-incolpare-qualcun-altro/
(5) The Limit of Detection (LoD) of most accredited laboratories is 10 ppm=mg/kg, for the established PCR method, and 0.75 ppm for the ELISA method, which, however, has non-negligible margins of uncertainty on complex matrices such as lecithin. In fact, the European Commission has not established an official method of analysis
(6) European Commission, DG Sante. Directorate G, Crisis management in food, animals and plants. Unit DDG2.G5, Alerts, traceability and committees Standard operating procedures of the Rapid Alert System for Food and Feed. Version 1, revision 6. V. RASFF SOP 5: Transmitting a notification to the ECCP. Paragraph 5, Classification (page 30). At https://bit.ly/3ui7ymA
(7) Assuming by default that each of the Campania industry’s 800 customers- themselves industries and/or food businesses or wholesale distributors-distributed the falsely qualified products as hazardous to an average of 12.5 of their professional customers (e.g., “I’m not sure how many of them are in the market. public establishments, food service, supermarkets, stores), the number of businesses involved in this Kafkaesque affair is 10,000,
(9) Marta Strinati. Allergen labeling, the great chaos. The Utrecht study. GIFT (Great Italian Food Trade). 9.8.21,
(9) Dario Dongo. Allergies in restaurants, danger guaranteed. German study. GIFT (Great Italian Food Trade). 26.5.19,
(10) Dario Dongo. https://www.greatitalianfoodtrade.it/sicurezza/reg-ue-2081-382-cultura-della-sicurezza-redistribuzione-alimenti-gestione-allergeni/. GIFT (Great Italian Food Trade). 9.3.21,
Dario Dongo, lawyer and journalist, PhD in international food law, founder of WIISE (FARE - GIFT - Food Times) and Égalité.
